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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04607837
Registration number
NCT04607837
Ethics application status
Date submitted
23/10/2020
Date registered
29/10/2020
Date last updated
15/07/2025
Titles & IDs
Public title
Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis
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Scientific title
A Randomized, Double Blind, Placebo Controlled, 52 Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately Active Ulcerative Colitis
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Secondary ID [1]
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2020-003507-34
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Secondary ID [2]
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APD334-210
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Universal Trial Number (UTN)
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Trial acronym
GLADIATOR UC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Etrasimod
Treatment: Drugs - Placebo
Experimental: Etrasimod 2 mg -
Placebo comparator: Placebo -
Treatment: Drugs: Etrasimod
Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
Treatment: Drugs: Placebo
Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving Clinical Remission (CR) at Week 52 Using Modified Mayo Score (MMS)
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Assessment method [1]
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MMS is used to assess disease activity in participants with UC and has following components: endoscopic score(ES),rectal bleeding(RB),stool frequency(SF).Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease.ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy,scores ranged from 0(normal or inactive disease) to 3(severe disease \[spontaneous bleeding, ulceration\]).RB reported most severe amount of blood passed per rectum in 24-hour period,scores ranged from 0(no blood seen) to 3(blood alone passes).SF reported number of stools in 24-hour period relative to normal number of stools for that participant in same period,scores ranged from 0(normal number of stools) to 3(5 or more stools than normal).CR per FDA draft guidance defined as:SF=0 or 1 and no greater than baseline, RB=0,ES less than or equal to (\<=)1(excluding friability).Percentage of participants achieving CR at Week 52 was evaluated.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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0
Percentage of Participants Achieving Clinical Remission at Week 12 Using MMS
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Assessment method [1]
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MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe); higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]). RB reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes). SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance was defined as: SF=0 or =1 and no greater than baseline, RB=0, and ES \<=1 (excluding friability). Percentage of participants achieving CR at Week 12 was evaluated in this endpoint.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Percentage of Participants Achieving Endoscopic Improvement at Week 52
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Assessment method [2]
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Endoscopic improvement was defined as ES \<=1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. Percentage of participants achieving endoscopic improvement at Week 52 was evaluated in this endpoint.
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Timepoint [2]
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0
Week 52
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Secondary outcome [3]
0
0
Percentage of Participants Achieving Symptomatic Remission at Week 52
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Assessment method [3]
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0
Symptomatic remission was defined as SF =0 (or = 1 with a \>= 1 point decrease from baseline) and RB =0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving symptomatic remission at Week 52 was evaluated in this endpoint.
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Timepoint [3]
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0
Week 52
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Secondary outcome [4]
0
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Percentage of Participants Achieving Complete Symptomatic Remission at Week 52
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Assessment method [4]
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0
Complete symptomatic remission was defined as participants with RB = 0 and SF = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving complete symptomatic remission at Week 52 was evaluated in this endpoint.
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Timepoint [4]
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0
Week 52
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Secondary outcome [5]
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Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 52
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Assessment method [5]
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Histologic-endoscopic mucosal improvement was defined as ES \<=1 (excluding friability) with Geboes score \<2.0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. The Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving mucosal improvement at Week 52 was evaluated in this endpoint.
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Timepoint [5]
0
0
Week 52
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Secondary outcome [6]
0
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Percentage of Participants Achieving Clinical Remission at Both Weeks 12 and 52 [Combined] Using MMS
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Assessment method [6]
0
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MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); higher scores = more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease). RB: reported the most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0 (no blood seen) to 3 (blood alone passes). SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). Clinical remission per FDA draft guidance: SF =0 or =1 and no greater than baseline, RB =0, and ES \<=1 (excluding friability). Percentage of participants who achieved clinical remission at both the time points Week 12 and Week 52 \[Combined\] are reported.
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Timepoint [6]
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Weeks 12 and 52 [Combined]
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Secondary outcome [7]
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Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS
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Assessment method [7]
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MMS has following components:ES, RB and SF. Each component score ranges from 0 to 3(0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease. ES:worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease)to 3(severe disease). RB:most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen)to 3(blood alone passes). SF:number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools)to 3(5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES \<=1(excluding friability). 12-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for \>=12 weeks immediately prior to Week 52. The baseline was balanced between treatment groups and representative of participants with mildly to moderately active UC.
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Timepoint [7]
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Week 52
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Secondary outcome [8]
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0
Percentage of Participants With 12-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS
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Assessment method [8]
0
0
MMS has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal,1=mild,2=moderate,3=severe); higher scores indicating more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES \<=1(excluding friability). 12-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for \>=12 weeks immediately prior to Week 52.
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Timepoint [8]
0
0
Week 52
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Secondary outcome [9]
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0
Percentage of Participants Achieving 4-Week Corticosteroid-Free Clinical Remission at Week 52 Among Participants Receiving Corticosteroids at Baseline Using MMS
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Assessment method [9]
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0
MMS has following components: ES, RB and SF; each ranged as 0=normal,1=mild,2=moderate,3=severe; total MMS score 0-9; higher scores=more severe disease. ES:worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease)to 3(severe disease). RB:most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3(blood alone passes). SF:number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0(normal number of stools)to 3(5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES \<=1(excluding friability). 4-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for \>=4 weeks immediately prior to Week 52. The baseline was balanced between treatment groups and representative of participants with mildly to moderately active UC.
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Timepoint [9]
0
0
Week 52
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Secondary outcome [10]
0
0
Percentage of Participants With 4-Week Corticosteroid-Free Clinical Remission at Week 52 Using MMS
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Assessment method [10]
0
0
MMS has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0=normal,1=mild,2=moderate,3=severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES: worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0(normal or inactive disease) to 3 (severe disease). RB: most severe amount of blood passed per rectum in a 24-hour period, score ranged from 0(no blood seen) to 3 (blood alone passes). SF: number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal). CR per FDA draft guidance as: SF =0 or =1 and no greater than baseline, RB=0, and ES \<=1(excluding friability). 4-week corticosteroid-free CR was defined as CR at Week 52 and corticosteroid-free for \>=4 weeks immediately prior to Week 52.
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Timepoint [10]
0
0
Week 52
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Secondary outcome [11]
0
0
Percentage of Participants Achieving Clinical Response at Week 12 Using MMS
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Assessment method [11]
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0
Clinical response was defined as a \>=2-point and \>=30 percentage (%) decrease from baseline in MMS, and a \>=1-point decrease from baseline in RB subscore or an absolute RB subscore \<=1 and is as per FDA draft guidance. MMS was used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component score ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, score ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]). Percentage of participants achieving clinical response at Week 12 was evaluated in this endpoint.
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Timepoint [11]
0
0
Week 12
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Secondary outcome [12]
0
0
Percentage of Participants Achieving Clinical Response at Week 52 Using MMS
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Assessment method [12]
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0
Clinical response was defined as a \>=2-point and \>=30 % decrease from baseline in MMS, and a \>=1-point decrease from baseline in RB subscore or an absolute RB subscore \<=1 and is as per FDA draft guidance. MMS is used to assess disease activity in participants with UC and has following components: ES, RB and SF. Each component scores ranges from 0 to 3 (0= normal, 1= mild, 2= moderate, 3= severe); where total score is sum of three components giving total MMS score as 0 to 9; higher scores indicating more severe disease. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]). Percentage of participants achieving clinical response at Week 52 was evaluated in this endpoint.
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Timepoint [12]
0
0
Week 52
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Secondary outcome [13]
0
0
Percentage of Participants Achieving Endoscopic Improvement at Week 12
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Assessment method [13]
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Endoscopic improvement was defined as ES \<=1 (excluding friability). ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. Percentage of participants achieving endoscopic improvement at Week 12 was evaluated in this endpoint.
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Timepoint [13]
0
0
Week 12
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Secondary outcome [14]
0
0
Percentage of Participants Achieving Histologic-Endoscopic Mucosal Improvement at Week 12
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Assessment method [14]
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0
Histologic-endoscopic mucosal improvement was defined as ES \<=1 (excluding friability) with Geboes score \<2.0. ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. The Geboes score grading system was a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving mucosal improvement at Week 12 was evaluated in this endpoint.
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Timepoint [14]
0
0
Week 12
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Secondary outcome [15]
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Percentage of Participants Achieving Symptomatic Remission at Week 12
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Assessment method [15]
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Symptomatic remission was defined as SF =0 (or = 1 with a \>= 1 point decrease from baseline) and RB =0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving symptomatic remission at Week 12 was evaluated in this endpoint.
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Timepoint [15]
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0
Week 12
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Secondary outcome [16]
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0
Percentage of Participants Achieving Complete Symptomatic Remission at Week 12
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Assessment method [16]
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Complete symptomatic remission was defined as participants with RB = 0 and SF = 0. SF subscore: reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, scores ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. RB subscore: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. Percentage of participants achieving complete symptomatic remission at Week 12 was evaluated in this endpoint.
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Timepoint [16]
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Week 12
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Secondary outcome [17]
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Percentage of Participants Achieving Change From Baseline in Both ES and RB or in Both ES and SF at Week 12
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Assessment method [17]
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ES reported worst appearance of mucosa on flexible sigmoidoscopy or colonoscopy, scores ranged from 0 (normal or inactive disease) to 3 (severe disease \[spontaneous bleeding, ulceration\]), higher scores = more severity. RB: reported the most severe amount of blood passed per rectum in a 24-hour period, scores ranged from 0 (no blood seen) to 3 (blood alone passes), higher scores = more severity. SF reported number of stools in a 24-hour period relative to normal number of stools for that participant in the same period, score ranged from 0 (normal number of stools) to 3 (5 or more stools than normal), higher scores = more severity. Percentage of participants with reduction from baseline in both ES and RB or in both ES and SF at Week 12 was evaluated in this endpoint. The baseline primary analysis set was balanced between treatment groups and representative of participants with mildly to moderately active UC.
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Timepoint [17]
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Baseline to Week 12
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Secondary outcome [18]
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Percentage of Participants Achieving Histologic Response Based on the Geboes Grading System at Week 12
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Assessment method [18]
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Histologic response based on the Geboes grading system was defined as Geboes score \<=3.1. The Geboes score grading system is a validated score for evaluating histologic disease activity in UC as follows: grade 0 = structural and architectural changes; grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher Geboes score indicated more severe disease. Percentage of participants achieving histologic response based on the Geboes grading system at week 12 was evaluated in this endpoint.
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Timepoint [18]
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0
Week 12
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Secondary outcome [19]
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Percentage of Participants Achieving Histologic Response Based on Robarts Histopathology Index (RHI) at Week 12
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Assessment method [19]
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RHI is an evaluative index, derived from the Geboes score, that is designed to be reproducible and responsive to clinically meaningful change in disease activity over time. Histologic response based on RHI was defined as decrease in RHI of \>=7 points from baseline. Total RHI score ranges from 0 (no disease activity) to 33 (severe disease activity), higher score = more severity. Percentage of participants achieving histologic response based on RHI at Week 12 was evaluated in this endpoint.
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Timepoint [19]
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Week 12
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Eligibility
Key inclusion criteria
* Diagnosed with Ulcerative Colitis (UC) = 3 months prior to screening
* Active UC confirmed by endoscopy
* Moderately active UC defined as a modified Mayo score of 4 to 6 and an endoscopic score = 2 and rectal bleeding score = 1
* Received a surveillance colonoscopy within 12 months before baseline
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Severe extensive colitis
* Diagnosis of Crohn's disease or indeterminate colitis or the presence or history of a fistula consistent with Crohn's disease
* Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis
* Hospitalization for exacerbation of UC requiring intravenous steroids within 12 weeks prior to or after screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/04/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/06/2024
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Sample size
Target
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Accrual to date
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Final
234
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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0
Queensland Respiratory Services ,Pulse Oceanside Medical{PFT Facility ) - Birtinya
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Recruitment hospital [2]
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Sunshine Coast Radiology - Birtinya
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Recruitment hospital [3]
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0
Sunshine Coast University Private Hospital - Birtinya
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Recruitment hospital [4]
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0
Buderim Eye Centre( OCT and Ophthalmoscopy Facility) - Buderim
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Recruitment hospital [5]
0
0
Coral Sea Clinical Research Institute Pty.Ltd - Mackay
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Recruitment hospital [6]
0
0
Coastal Digestive Helath Pty. Ltd - Maroochydore
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Recruitment hospital [7]
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Dr.Shiran DeSilva Respiratory Clinic (PFT) - North Mackay
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Recruitment hospital [8]
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0
Mater Misericordiae Hospital ( Endoscopy) - North Mackay
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Recruitment hospital [9]
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Queensland X-Ray - North Mackay
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Recruitment hospital [10]
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Vision Eye Institute Mackay (OCT) - North Mackay
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Recruitment hospital [11]
0
0
Austin Health - Heidelberg
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Recruitment hospital [12]
0
0
Melbourne Health - Parkville
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Recruitment postcode(s) [1]
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0
4575 - Birtinya
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Recruitment postcode(s) [2]
0
0
4575 - Buderim
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Recruitment postcode(s) [3]
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0
4740 - Mackay
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Recruitment postcode(s) [4]
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0
4558 - Maroochydore
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Recruitment postcode(s) [5]
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0
4740 - North Mackay
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Recruitment postcode(s) [6]
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0
3084 - Heidelberg
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Recruitment postcode(s) [7]
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0
3050 - Parkville
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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0
0
United States of America
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0
0
Arizona
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0
0
United States of America
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0
0
California
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0
0
United States of America
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0
0
Colorado
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0
0
United States of America
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0
0
Florida
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0
0
United States of America
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0
0
Illinois
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0
0
United States of America
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0
0
Maryland
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0
0
United States of America
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0
0
New Hampshire
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United States of America
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0
Ohio
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0
0
United States of America
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0
0
Pennsylvania
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0
0
United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Belarus
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Gomel
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0
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Belarus
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Grodno
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Belarus
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Vitebsk
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Belgium
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0
Roeselare
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0
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Bulgaria
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0
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Ruse
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0
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Bulgaria
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Sofia
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0
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Bulgaria
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0
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Veliko Tarnovo
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Czechia
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0
Boskovice
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Czechia
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Hradec Kralove
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0
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Czechia
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Olomouc
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Czechia
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Ostrava-Poruba
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Prerov
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France
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Ukraine
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Vinnytsya
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Arena is a wholly owned subsidiary of Pfizer
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.
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Trial website
https://clinicaltrials.gov/study/NCT04607837
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/37/NCT04607837/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/37/NCT04607837/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04607837
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